Evidence map›Paper›PMID 34228250›Full record

Observational studyClinical and experimental nephrology2021

Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOW-PKD surveillance.

Toshio Mochizuki, Satoru Muto, Masateru Miyake, Toshiki Tanaka, Wenchyi Wang

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Clinical and experimental nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Article
  3. Observational
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Toshio MochizukiDepartment of Nephrology, Tokyo Women's Medical University, Tokyo, Japan.
Satoru MutoDepartment of Urology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Masateru MiyakeDepartment of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-ku, Osaka, 540-0021, Japan. Miyake.Masateru@otsuka.jp.ORCID http://orcid.org/0000-0003-4557-0886
Toshiki TanakaDepartment of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-ku, Osaka, 540-0021, Japan.
Wenchyi WangOtsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTolvaptan is a vasopressin type 2 receptor antagonist and has been used to treat autosomal dominant polycystic kidney disease (ADPKD) since 2014. There has been limited real-world data on the safety and efficacy of tolvaptan.

methodsThis post-marketing surveillance was conducted to evaluate the long-term safety and the efficacy of tolvaptan in Japanese patients with ADPKD in real-world clinical settings. The baseline characteristics of 1630 patients treated with tolvaptan are reported. Safety analysis comprises evaluation of adverse drug reactions (ADRs). The efficacy evaluation includes percent change in total kidney volume (TKV) and change in estimated glomerular filtration rate (eGFR) before and after tolvaptan treatment.

resultsMean age was 49.7 ± 11.2 years and 843 (51.7%) patients were male. Baseline TKV was 2158 ± 1346 mL and eGFR was 44.4 ± 21.7 mL/min/1.73 m

conclusionThere were no major problems with safety of tolvaptan treatment and comparable efficacy for TKV and eGFR was observed in relation to the previous pivotal two randomized control trials in this post-marketing surveillance.

Indexed as

AdultAlanine TransaminaseAntidiuretic Hormone Receptor AntagonistsChemical and Drug Induced Liver InjuryFemaleGlomerular Filtration RateHumansHyperuricemiaJapanKidneyMaleMiddle AgedOrgan SizePolycystic Kidney, Autosomal DominantProduct Surveillance, PostmarketingProspective StudiesAlanine TransaminaseAntidiuretic Hormone Receptor AntagonistsTolvaptanAutosomal dominant polycystic kidney diseaseGlomerular filtration ratePost-marketing surveySafety profileTolvaptanTotal kidney volume

Identifiers

PMID34228250
PMCPMC8460520

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.